Pfizer cites packaging flaws in birth control pill recall

A correctly packaged Lo/Ovral pack. Lo/Ovral was one of the brands involved in the Pfizer recall.
(Pfizer)

[summary]

Drug maker Pfizer Inc. recalled about a million packs of birth-control pills that weren't packaged correctly, which raised the risk of unplanned pregnancies among women who relied on the pills.

Pulled from shelves were Lo/Ovral-28 pills and their Norgestrel generic versions, which doctors have been prescribing for years to tens of thousands of women. The pills come in blister packs containing a mix of 21 active tablets and seven that are inert. As guided by the packs, women are supposed to take a certain pill each day in order to prevent pregnancy, taking the inert pills at the end of a monthly cycle.

Pfizer said Wednesday that it believes only 30 packs had packaging problems, including having the active and inert tablets out of order, or lacking the proper amount of each kind of pill. The company said it recalled a million packs in the U.S. to be safe.

The Food and Drug Administration hasn't received any reports of adverse events, such as unintended pregnancies, and the agency is investigating, according to an agency spokeswoman. Pfizer said it hadn't received reports either, while noting that it had only just alerted the public.

The pills were made and shipped last year by a Pfizer plant in upstate New York, on the Canadian border. To encourage proper use, active pills in the packs are colored white, while the inert tablets are pink. An alert customer noticed that her pack had a pink pill where a white one should have been, and complained to the company on Oct. 19, a Pfizer spokeswoman said.

Investigating the complaint, Pfizer discovered that some blister packs of pills had an extra active pill at day 22 or 28, one pack lacked an active tablet at day 10 and another pack lacked a placebo tablet at day 24, the FDA spokeswoman said.

Pfizer identified three glitches in its production of the packs that could, on rare occasion, result in improper packaging, a Pfizer spokeswoman said. The problems: The design of the packaging line could allow for incorrect placement of the pills; a mechanical system for detecting defective packs could miss one in "very, very infrequent" times; and plant workers could also miss problem packs. The company said it has since fixed the problems.

Pfizer notified pharmacies and distributors on Dec. 28 that it was recalling the pills, according to an FDA spokeswoman. The company believed, based on the "low defect rate and our health-hazard assessment," that providing public notice wasn't necessary, but then went public late Tuesday following an FDA request, a Pfizer spokeswoman said.

Women who miss birth-control pills—say, by taking an inert pill when they should take an active one—are at risk of an unintended pregnancy because they may ovulate in the absence of the hormonal medicines meant to prevent it.